FDA Regulatory Advisory And Quality System Framework Engagements

Discover The Projects

Some clients arrive at FDA medical device development without an existing quality system or a clear path to one. The framework has to be built, or substantially adjusted, before product engineering can move at all. The clients below each came to Good Automation early in that arc, with the regulatory question on the table, not just the engineering question.

Good Automation engaged each client on the regulatory framing first: validation strategy and 21 CFR Part 11 implications for a Class III Software as a Medical Device, on-the-ground FDA quality system training for a foreign company entering the US market, and a minimally viable QMS plus design history file for university researchers moving lab work toward commercialization. Three different starting points, one consistent posture: regulatory clarity is faster and cheaper than retrofitting compliance later.

Class III tissue tracking SaMD FDA validation advisory

For Class III Software as Medical Device Company: Provided FDA validation advisory services for a company developing Class III Software as a Medical Device (SaMD) for corneal tissue management.

FDA medical device regulatory guidance for e-cigarettes

For Electronic Cigarette Manufacturer: Traveled to Tel Aviv, Israel to help an electronic cigarette (ENDS) company understand and meet US FDA medical device regulations.

Consumer Electronics FDA Regulated

Medical device QMS and design history for commercialization

For Major Research University: Developed a minimally viable Quality Management System (QMS) and design history file for University of Texas researchers seeking to commercialize early-stage medical device research.

FDA Regulated Medical Device

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Project Highlights

3-project engagement covering complementary scopes under one engineering relationship.
Capability mix: Consumer Electronics, FDA Regulated, Medical Device, Verification & Validation.
Work performed in the context of FDA quality system requirements where the customer's regulatory framework demanded it: non-product software V&V per 21 CFR 820.70(i) and electronic-records compliance per 21 CFR Part 11 as applicable.